A device for the analysis of biological material, in which a test sample holder is inserted into a measuring device, is known from DE 69915481 T2. The analysis of biological material, for example, human saliva, is described in DE 19751363 B3. It is necessary here, in a sequence of process steps, to collect a sample of the biological material in a suitable tank, to meter a defined quantity of an aqueous developer solution, and to insert the mixture of aqueous solution and biological material into a test sample holder, into which a test strip is placed. The test strip contains a collection matrix and a detection matrix. The presence or absence of an analyte in the collected biological material is demonstrated by an immunochemical detection reaction. The presence of the analyte to be detected in the sample of the biological material causes a color change on the test strip in the detection reaction.
The device known from DE 69915481 T2 uses an optical analysis unit for the analysis of the color change. A combination of immunochemical detection reaction and chromatographic analysis is thus obtained. The course of the immunochemical reaction depends essentially on the processing times and ambient conditions, the rate of the reaction process and hence the reproducibility of the detection of an analyte in a sample of biological material being affected especially by the temperature.
A test sample holder for collecting a quantity of biological material is known from DE 19546565 A1, and another embodiment of a test sample holder is known from US 20010034068 A1.
Parts of the analytical process step, e.g., the collection of the sampler and the metering with the developing fluid onto the sample take place outside the device in the device specified in DE 69915481 T2. It is disadvantageous in such an embodiment that the effects of the ambient conditions, especially of the temperature, cannot be controlled for the duration of the detection reaction. This limits the temperature range in which the measuring device can be used without affecting the reproducibility.
Furthermore, it is disadvantageous that the time period between the metering of the developer fluid onto the sample and the chromatographic analysis continues to be at the discretion of the user and thus also affects the subsequent measurement. The consequence of this is a fluctuation of the measurement results due to the process and, as a result, a greater measuring uncertainty over the entire measuring chain.